Identity
- Trade Name
- NICO Myriad EUDAMEDFDA UDI
- Generic Name
- Tissue morcellation system tissue preservation container FDA UDI
- Device Name
- Specimen Preserver FDA UDI
- Model / Reference
- NICO Myriad EUDAMEDNN-9006 EUDAMEDFDA UDI
- Description
- Specimen Preserver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744029067 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402MY5G4 EUDAMED
- FDA Product Code
- JRR FDA UDI
- EMDN Code
- A0980 ORGAN PRESERVATION SOLUTIONS AND CONTAINERS - ACCESSORIES EUDAMED
- GMDN Term
- Tissue morcellation system tissue preservation container FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NICO Myriad by NICO Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081674402MY5G4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED d1e719b7-b392-4eca-b7d8-c86f4771110e 61 fields · synced Jul 17, 2026
- FDA UDI e1aa7a9c-e4ef-4aa6-b226-8bc08658c59d 34 fields · synced May 26, 2026